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Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices
Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as confidential. Any information marked as confidential will not be disclosed except in accordance with 21 CFR 10.20
and other applicable disclosure law. For more information about FDAs posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https
www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the Search box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 2404027500.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A12M, 11601
Landsdown St., North Bethesda, MD
20852, 3017965733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA 44 U.S.C. 35013521, Federal Agencies must obtain approval from the Office of Management and Budget OMB for each collection of information they conduct or sponsor.
Collection of information is defined in 44 U.S.C. 35023 and 5 CFR
1320.3c and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party.
Section 3506c2A of the PRA 44
U.S.C. 3506c2A requires Federal
Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB
for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA invites comments on these topics: 1 Whether the proposed collection of information is necessary for the proper performance of FDAs functions, including whether the information will have practical utility; 2 the accuracy of FDAs estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; 3 ways to enhance the quality, utility, and clarity of the information to be collected; and 4
ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
Pilot Survey To Develop Standardized Reporting Forms for Federally Funded Public Health Projects OMB Control Number 0910NEW
This information collection supports federally funded public health projects administered by the Agencys Office of Regulatory Affairs ORA. As part of FDAs efforts to protect the public health, we work collaboratively with State partners to enhance oversight of FDA-regulated products. Consistent with applicable regulations pertaining to federally funded programs, we currently collect information related to an awardees progress in completing agreed-upon performance metrics 3 to 4
times a year during the performance period. Respondents to the information
collection are recipients of FDA-funded projects who submit required information to FDA in free text and narrative form via portable document format pdf. To increase our efficiency in evaluating program effectiveness and return-on-investment ROI/return-onvalue ROV for the federally funded projects that we administer, we intend to develop and establish the use of digital forms that contain standardized questions to capture data elements necessary to measure/track ROI/ROV.
We believe the use of standardized forms will reduce the time required by awardees in completing and submitting progress reports.
As part of the pilot, respondents will complete an initial report and progress/
performance reports, which include data fields to identify the award project and contact person and directs specific questions to respondents regarding project and progress updates. Based on public feedback, we hope to revise the reports, tailoring for project specificity and purpose, to include, but not limited to, improvements, such as drop-down menu selections and potential common response indicators that will reduce time for respondents and allow us to more quickly process information and determine impacts at the Agency level.
As information will be requested of actively funded projects, it may become necessary to request additional information for a particular project to complete the performance evaluations in a timely manner. To ensure data is sufficient, on a case-by-case basis, FDA
anticipates a need for followup questionnaires to supplement the progress reports as instruments of collection are developed and fine-tuned through this effort.
We estimate the burden of the information collection as follows:

TABLE 1ESTIMATED ANNUAL REPORTING BURDEN 1
Number of respondents
Awardee activity
Total annual responses
Average burden per response
Total hours
Initial Report
Progress Reports
Supplement or Followup Report if applicable

400
400
100

1
2 1

400
800
100

10
40
10

4,000
32,000
1,000

Total

37,000

1 There
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Number of responses per respondent
are no capital costs or operating and maintenance costs associated with this collection of information.

We estimate that 400 respondents will participate under this pilot project and will submit an average of 3 to 4 reports within a single budget year table 1. To
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ensure adequate reporting will be achieved over the course of this pilot, the option for a supplement or followup report is included in the estimated
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reporting burden; however, the need for these reports will be determined on a case-by-case basis with the FDA project manager.

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